Brazil Updates Dietary Supplement Regulations to Enhance Consumer Safety

On July 1, 2024, the Brazilian Health Regulatory Agency (ANVISA) officially published Ordinance INNo304 in the government gazette, amending the regulations on food supplement management (Ordinance No. 28 of 2018).

The detailed revisions cover multiple aspects aimed at further standardizing the dietary supplement market and ensuring consumer health and safety:

Firstly, the updated regulations allow the inclusion of substances such as fava bean powder, cherry laurel powder, hydroxytyrosol and its derivatives in the nutrient list for dietary supplements (Annex 1), providing a more diverse range of nutritional options.

Secondly, to address the specific needs of infants and toddlers (0-3 years), the revised regulations introduce beneficial bacteria such as Bifidobacterium R0052, Bifidobacterium R0033, and Bifidobacterium R0071 in the nutrient list for infant and toddler dietary supplements (Annex 2), supporting their healthy growth.

Furthermore, the updated regulations clearly define the list of nutrients that must be provided to consumers in the form of dietary supplements (Annex 3). For adults aged 19 and above, the addition of hydroxytyrosol and its derivatives is limited to 5-35 mg per serving to ensure safe and effective nutrient intake.

Regarding label claims, the revised regulations update the list of permitted claims for dietary supplements (Annex 5). The newly added bacteria, such as Bifidobacterium R0052, R0033, and R0071, can use the claim "supports gut health" when the supplementation meets the requirements in Annex 3, providing consumers with clearer purchasing guidance.

Finally, the updated labeling requirements (Annex 6) include new provisions for dietary supplements containing fava bean powder. These products must carry a warning that "Pregnant women, breastfeeding mothers, and children should not consume this product," to alert these special populations about food safety.

The INNo304 ordinance will come into effect immediately upon publication, and is expected to have a profound impact on the Brazilian dietary supplement market, further driving its standardization and scientific development.